IPhone Urinalysis Draws First FDA Inquiry of Medical Apps

[goldent]

2. I'd think they would need to deal with color accuracy of the camera, including ambient lighting

Perhaps the strip could be photographed on a calibration card. It is not a simple problem, and they need to clearly display the range of error in the output display.

Certification of medical devices can become very complex - in this case it is not as bad because with this class of device there is no direct risk of injury (worst case is misdiagnosis).

If they thought they could just start selling something like this as an Apple app, it makes me believe they aren't too experienced in developing medical devices. I would be worried that they did something fairly naive.